Tier - Palliative Care For Patients With Advanced Heart Failure or Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai

About this trial

TIER-PC is an adaptive model of delivering palliative care that provides the right level of care to the right patients at the right time. It represents an adaption of the Mount Sinai PALLIATIVE CARE AT HOME (PC@H) program, which delivers home-based palliative care. TIER-PC increases the number and intensity of disciplines added to the patient's care team as their symptoms worsen and function declines. In Tier 1, patients who are able to care for themselves and no/mild symptoms receive a community health worker (CHW) trained to elicit illness understanding in a culturally competent way. In Tier 2, for patients with poorer function and mild symptoms, a social worker (SW), trained in serious illness communication, joins the CHW to further elicit patients' goals and prognostic understanding while communicating symptom needs to their primary clinician. In Tier 3, as function decreases and symptoms increase, an advance practice nurse (APN) joins the CHW and SW to manage complex symptoms. Finally, in Tier 4, for those older adults with the poorest function and most complex symptoms, a physician joins the team to ensure that the most complex needs (e.g., end-of-life treatment preferences and multifaceted symptom control) are met. The CHW follows patients longitudinally across all tiers and re-allocates them to the appropriate tier based on their evolving needs.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Advanced Heart Failure (HF) with two HF-related hospitalizations within the last 12 months or

Advanced lung or non-colorectal gastrointestinal cancer (pancreatic, gastric, hepatobiliary, small bowel, esophageal) with one hospitalization within the last 6 months

KPS > 50% (ECOG 0, 1 or 2)

> 2 outpatient MSHS visits in prior 12 months

Disqualifiers

Diagnoses of both cancer and advanced HF

Lung cancer with a driver mutation (e.g., EGFR) that confers a favorable prognosis and does not follow typical trajectory

Patients with > 1 visit to Outpatient Supportive Oncology/Cardiology visit

Patients with last visit to Outpatient Supportive Oncology/Cardiology < 3 months ago

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tier-Palliative Care

    Behavioral

    TIER-PC is an adaptive model of delivering palliative care that provides the right level of care to the right patients at the right time. It represents an adaption of the Mount Sinai PALLIATIVE CARE AT HOME (PC@H) program, which delivers home-based palliative care. TIER-PC increases the number and intensity of disciplines added to the patient's care team as their symptoms worsen and function declines.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Tier-Palliative CareExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

The proportion of screened eligible patients

The proportion of screened eligible patients that are enrolled in the trial.

Time frame
3 months

Secondary outcomes

1

The proportion of patients completing the final 3-month visit

The proportion of the patients completing the final 3-month visit among all enrolled patients.

Time frame
3 months
2

Number of TIER-PC intervention visits received per patient per month

The fidelity to intervention is defined as the number of TIER-PC intervention visits received per patient per month in the TIER-PC arm during the follow-up period.

Time frame
3 months
3

Edmonton Symptom Assessment Scale (ESAS)

Patient symptoms will be measured (e.g., pain, shortness of breath) using the 9-item Edmonton Symptom Assessment Scale (ESAS) validated for serious illness. Each item is 10-point scale, total score ranges 0 (no symptoms) - 90 (worst severity), with higher scores indicating worse symptom severity.

Time frame
3 months
4

Quality of Life measured using Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-Pal)

Quality of life (QoL) using the Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-Pal), a 46-item QoL questionnaire validated in patients with advanced disease. Each item is scored on a 5-point Likert scale from 0 (not at all) - 4 (very much). Total score ranges 0-184, with higher scores indicating better quality of life.

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Icahn School of Medicine at Mount Sinai

Lead sponsor

National Institute of Nursing Research (NINR)

Collaborator